Trial Condition(s):

Prostatic Neoplasms

Incidence of second primary malignancies in prostate cancer patients with bone metastases – an observational retrospective cohort study in Sweden (SMARCOS)

Bayer Identifier:

18105 Identifier:


EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival in patients with castration resistant prostate cancer are of particular interest. Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)

Inclusion Criteria
mPC population; if the following criteria are fulfilled:
A.) PC diagnosis in 1.1.1998 – 31.12.2011
B.) Bone metastases diagnosis in 1.1.1999 – 31.12.2011
mCRPC population; if the following criteria are fulfilled:
1.) PC diagnosis in 1.1.1998 – 31.12.2011
2.) Bone metastases diagnosis in 1.1.2007 – 31.12.2011
3.) One of the following in 1.1.2006 – 31.12.2011 and before or at the same time with bone metastases diagnosis:
a.) Discontinuation of the initial chemical castration (androgen deprivation therapy, ADT), change of the agent or modality of ADT, or start of treatment for advanced PC after the primary ADT (including chemotherapy or mitoxantrone)
b.) Surgical castration and initiation of ADT treatment, chemotherapy or mitoxantrone afterwards
c.) Treatment with medication specific to either castration-resistant PC or mCRPC (cabazitaxel, enzalutamide or abiraterone).
d.) In a sensitivity analysis, also those who have had at least 6 months since the initiation of castration treatment before cohort entry date (bone metastases diagnosis) are included in the mCRPC population.
Exclusion Criteria
-  First PC diagnosis later than 2 months after the diagnosis of bone metastases, or
 - Permanent residence not in Sweden or patient otherwise not contributing to the registers at least a year before the diagnosis of bone metastases (patient counted not contributing also if database existence less than a year before cohort entry), or
 - Use of any radiopharmaceuticals for bone metastases (ATC code): Samarium (V10BX02), strontium (V10BX01), rhenium (V10BX03) or radium (V10XX03).

Trial Summary

Enrollment Goal
Trial Dates
Could I receive a placebo?
Accepts Healthy Volunteers

Where to Participate


Investigative Site

Many Locations, Sweden

Trial Design